EoE(Eosinophilic Esophagitis)

Not Applicable

Completed

• Conditions: Eosinophilic Esophagitis; Dysphagia
• Interventions: Procedure: Eosinophilic Esophagitis with Dysphagia

• Registration Number: NCT01999439
• Lead Sponsor: University of Michigan

Brief Summary

To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive, radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and stiffness) and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food impaction.

Detailed Description

Eosinophilic esophagitis(EoE) is a form of chronic inflammation affecting the esophagus which often results in wall thickening and esophageal stiffening and is associated with complications, such as esophageal tears and strictures (narrowings). Chronic dysphagia and acute food impaction (swallowed food stuck in the esophagus) are common symptoms of EoE and are associated with esophageal wall thickening and stiffness.

Current diagnostic techniques such as endoscopy with biopsy give only limited information about changes in the esophageal wall in eosinophilic esophagitis(EoE). In routine clinical practice, repeat endoscopic evaluation with biopsy is commonly performed about 3-6 months after initial therapy for eosinophilic esophagitis(EoE). However, follow-up endoscopy with biopsy has drawbacks as it is invasive, costly and typically requires deep sedation or general anesthesia.

We propose to evaluate quantitative MRI as a potential non-invasive diagnostic option for evaluating esophageal wall remodeling in patients with eosinophilic esophagitis(EoE).

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Study Start: 2014-01
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Pediatric patients ages 8 to 18 years of age.
2. Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction.
3. Pediatric patients newly diagnosed with Eosinophilic Esophagitis -

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Exclusion Criteria

1. Are not able to undergo an MRI without needing sedation or general anesthesia
2. Are allergic to gadolinium-based contrast material
3. Have an ongoing acute kidney injury
4. Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of <40 ml/min.
5. Have a presence of eosinophilia involving the stomach and/or esophagus.
6. Have a prior history of caustic ingestion
7. Have a prior history of esophageal surgery, including history of tracheoesophageal fistula.
8. Have known celiac disease
9. Have known Crohn's disease
10. Have known malignancy
11. Have hypereosinophilic syndrome
12. Have recent history of parasitic infection
13. Have known inflammatory bowel disease -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eosinophilic Esophagitis with Dysphagia	Eosinophilic Esophagitis with Dysphagia	To assess quantitative magnetic resonance imaging(MRI)as a potential diagnostic tool for evaluating esophageal wall thickness and stiffness and response to treatment in children and adolescents with a diagnosis of eosinophilic esophagitis (EoE) presenting with difficulty swallowing(dysphagia)and food impaction.

Primary Outcome Measures

Name	Time	Method
Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis	2 years	To assess noninvasive quantitative magnetic resonance imaging (MRI) based biomarkers in the evaluation of esophageal wall remodeling and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis presenting with dysphagia. Magnetic resonance imaging (MRI)findings will be correlated with the endoscopic appearance of the esophagus, histologic findings, and clinical symptoms.

Trial Locations

Locations (1)

University of Michigan C. S. Mott Childrens Hospital; 🇺🇸 Ann Arbor, Michigan, United States